Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
NCT ID:
NCT00001032
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Recommended:
* PCP prophylaxis.
Allowed:
* Intravenous and/or intramuscular immunoglobulin.
* Acyclovir (no more than 30 mg/kg/day PO).
* Ketoconazole (no more than 10 mg/kg/day).
* Nystatin.
* Aspirin, acetaminophen, nonsteroidal anti-inflammatory drugs, sedatives, and barbiturates, not to exceed 72 hours.
* Isoniazid in combination with pyridoxine, provided there is no evidence of peripheral neuropathy.
* Trimethoprim / sulfamethoxazole.
* Amphotericin B (no more than 1 mg/kg for 5 days/week).
* Aerosolized ribavirin for bronchiolitis.
* Hematopoietic agents.
* Other drugs with little nephro-, hepato-, or cytotoxicity.
* Nutritional support for HIV wasting syndrome or malnutrition.
Patients must have:
* HIV infection.
* Ongoing stable AZT therapy.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
* Disease progression while on AZT, to the extent that the patient meets the criteria for advanced disease protocols.
* Known allergy or sensitivity to ddC.
* Cardiomyopathy.
Concurrent Medication:
Excluded:
* Biologic modifiers other than IVIG, steroids, or hematopoietic agents.
* Investigational medications unless approved by protocol chair.
* Medications known to cause pancreatitis (unless ddC is interrupted while these medications are given).
Patients with the following prior conditions are excluded:
* History of intolerance or toxicity to AZT.
* History of symptomatic pancreatitis.
* History of peripheral neuropathy or abnormal nerve conduction velocity test.
Prior Medication:
Excluded:
* Antiretroviral agents other than AZT within 2 weeks of study entry.
Required:
* Ongoing stable AZT therapy for more than 6 weeks duration.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
12 Years
Study:
NCT00001032
Study Brief:
Protocol Section:
NCT00001032